capa management process flow chart | Operon Strategist

1. CAPA CAPA MANAGEMENT MANAGEMENT Call / Whatsapp - 9325283428 www.operonstrategist.com

2. What is CAPA management? What is CAPA management? ■ The CAPA CAPA management system is the cornerstone of a Quality Management System, especially in the Pharmaceutical/Medical Device Industry and the backbone and driver for quality improvements. The (Corrective And Preventive Action Corrective And Preventive Action) CAPA management system feeds the Quality System to improve processes, procedures, organization and business in a structured, well-documented and actionable way. ■ Operon Strategist audits CAPA management system of clients determines how effective it is in identifying & correcting quality problems. An effective Corrective And Preventive Action system enables easy collection & analysis of information. This information is used to identify & investigate existing; potential product & quality problems audits the existing (Corrective And Preventive Action) Call / Whatsapp - 9325283428 www.operonstrategist.com

3. CAPA Management Process Flow Chart ■ PDCA cycle is one of the manageable and easiest processes to deal with any situation or problem-related to process control and continuous improvement. The PDCA cycle is used for a new product or for conceptualization, problem-solving, project performance and many other fields. PDCA cycle is mostly used in the software field for Software development lifecycle. The PDCA cycle is normally used in manufacturing and Service industries for new product development and also finds its place in Project Management of any field. Specifically, areas like change management also use the PDCA cycle for their implementation. Call / Whatsapp - 9325283428 www.operonstrategist.com

4. There is a strong link between QUALITY and OPERATIONAL There is a strong link between QUALITY and OPERATIONAL EXCELLENCE, as a well EXCELLENCE, as a well- -established CAPA management system established CAPA management system will have its benefits for the business, for instance: will have its benefits for the business, for instance: ■ Improved safety and security ■ Improved customer satisfaction ■ Increased productivity ■ Infrastructure efficiency gains ■ Better product quality ■ Avoiding the cost of regulatory non-compliance Call / Whatsapp - 9325283428 www.operonstrategist.com

5. ■ The risk-based CAPA determines the root cause of non-conformances, system failures or process problems, corrects the problems, and prevents them from recurring. The documentation must identify why something went wrong—or why it may go wrong— and what has been done to make sure it does not happen again.One of the most important quality system elements is the corrective and preventive action subsystem. And its purpose of this corrective and preventive action subsystem is to collect information, analyze information, identify and investigate product and quality problems, and take appropriate and effective corrective and/or preventive action to prevent their recurrence. In an industry where patients health and wellness depends on products functioning properly, an organization cannot afford any weak areas that could lead to nonconformities or lower quality products CAPA requirements demand a well-documented system that Call / Whatsapp - 9325283428 www.operonstrategist.com

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